35 results on '"Soria, Angèle"'
Search Results
2. Risk stratification through extensive allergy work‐up in COVID‐19‐mRNA vaccine allergic reactions.
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Soria, Angèle, Labella, Marina, Doña, Inmaculada, Nicaise‐Roland, Pascale, Chollet‐Martin, Sylvie, Autegarden, Jean‐Eric, Castagna, Julie, Le Thai, Claire, de Chaisemartin, Luc, Torres, Maria José, and Barbaud, Annick
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ALLERGIES , *VACCINES , *ANAPHYLAXIS , *SKIN tests , *POLYETHYLENE glycol - Abstract
In 145 patients, revaccination was performed with the culprit vaccine, which was well tolerated in 126 of the patients, and 15 of the patients had an alternative COVID-19 vaccine (other mRNA vaccine for 12), which was well tolerated in 13 of the patients (Figure 1). Keywords: allergy; anaphylaxis; COVID-19-mRNA vaccines EN allergy anaphylaxis COVID-19-mRNA vaccines 2320 2323 4 08/02/23 20230801 NES 230801 To the Editor, The mechanisms of allergic reactions to COVID-19-mRNA vaccines have not been elucidated. One hundred and sixty patients (84%) were revaccinated (122 under antihistamine premedication), 139 patients (87%) had good tolerance, and 30 patients refused further COVID-19 vaccination. [Extracted from the article]
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- 2023
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3. Allergic contact dermatitis caused by PEG‐22 and PEG‐45 dodecyl glycol copolymers in two skin‐repairing creams.
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Brehon, Alice, Soria, Angèle, Barbaud, Annick, and Amsler, Emmanuelle
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ETHYLENE glycol , *CONTACT dermatitis , *COPOLYMERS , *GLYCOLS , *ECZEMA , *BENZYL alcohol - Abstract
Keywords: allergic contact dermatitis; CAS no. 78336-31-9; case report; copolymers; cosmetic products; PEG-22/dodecyl glycol copolymer; PEG-45/dodecyl glycol copolymer EN allergic contact dermatitis CAS no. 78336-31-9 case report copolymers cosmetic products PEG-22/dodecyl glycol copolymer PEG-45/dodecyl glycol copolymer 213 215 3 08/04/23 20230901 NES 230901 We report a case of allergic contact dermatitis (ACD) caused by PEG-22/dodecyl glycol copolymer and PEG-45/dodecyl glycol copolymer contained in two different "skin-repairing" creams. Allergic contact dermatitis, CAS no. 78336-31-9, case report, copolymers, cosmetic products, PEG-22/dodecyl glycol copolymer, PEG-45/dodecyl glycol copolymer Allergic contact dermatitis caused by PEG-22 and PEG-45 dodecyl glycol copolymers in two skin-repairing creams. [Extracted from the article]
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- 2023
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4. Systemic inflammatory trunk recurrent acute macular eruption (SITRAME): A new auto-inflammatory syndrome in adult?
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Soria, Angèle, Amsler, Emmanuelle, Garel, Bethsabée, Moguelet, Philippe, Tieulié, Nathalie, Cordoliani, Florence, Guichar, Isabelle, Mahé, Antoine, Grateau, Gilles, Boursier, Guilaine, and Georgin-Lavialle, Sophie
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ADULTS , *SYNDROMES - Published
- 2023
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5. Chronic inducible urticaria a particular form of chronic urticaria.
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Soria, Angèle
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URTICARIA , *ANAPHYLAXIS , *JAPANESE women , *YOUNG adults - Abstract
Chronic spontaneous urticaria (CSU) is characterized by recurring hives and/or angioedema lasting for at least 6 weeks, while Chronic Inducible Urticaria (CIndU) is triggered by specific stimuli. A recent Turkish study analyzed 423 patients with different types of CIndU and found that isolated CIndU was more common than cases where CSU coexisted with CIndU. The study also identified demographic differences among CIndU subtypes, with cholinergic urticaria affecting younger male patients more frequently. Systemic reactions were observed in some subtypes of CIndU, such as cold urticaria and cholinergic urticaria, but not in CSU. Understanding the distinct clinical presentations of CIndU subtypes is important for developing appropriate therapeutic approaches. [Extracted from the article]
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- 2024
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6. General Burden of Adult Atopic Dermatitis: An Observational Study of Disease Perceptions among Patients and Dermatologists in France.
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SORIA, Angèle, THÉNIÉ, Claire, BIENENFELD, Christina, and STAUMONT-SALLÉ, Delphine
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ATOPIC dermatitis , *PATIENTS' attitudes , *DERMATOLOGISTS , *ADULTS , *SCIENTIFIC observation - Abstract
It is important to understand patients' and dermatologists' perceptions of various aspects of atopic dermatitis, but there is a lack of studies on quality of life and stakeholder viewpoints in this therapy area. The aim of this study was to compare patients' and dermatologists' viewpoints regarding the impact of atopic dermatitis that is uncontrolled by topical corticosteroids. Data were collected from 348 adult patients who responded to self-administered questionnaires, and 150 telephone interviews with the dermatologists who selected them. Patients and dermatologists reported both convergent and divergent assessments of the impact of atopic dermatitis and its treatment. Notable areas of agreement were regarding the safety of emollients, the time required and difficulty of applying topical corticosteroids, especially to certain parts of the body. Divergent views involved the perceived efficacy of available treatments and the impact of atopic dermatitis on professional life. A greater understanding of these differences would help dermatologists to optimize patient care. [ABSTRACT FROM AUTHOR]
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- 2021
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7. Allergological workup with half‐dose challenge in iodinated contrast media hypersensitivity.
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Soria, Angèle, Masson, Nathalie, Vial‐Dupuy, Amandine, Gaouar, Hafida, Amsler, Emmanuelle, Chollet‐Martin, Sylvie, Nicaise‐Roland, Pascale, Autegarden, Jean‐Eric, and Barbaud, Annick
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RADIOGRAPHIC contrast media , *ALLERGIES , *ANTIALLERGIC agents - Abstract
The article offers information on the diagnosis of hypersensitivity reaction (HSR) to iodinated contrast media (ICM) is challenging when based on clinical history and skin tests. It mentions the objective of this study was to determine the negative predictive value (NPV) for skin tests as compared with the intravenous provocation tests (IPT) 50 mL; and also mentions the IPT was reduced to 10 mL with glomerular filtration rate (GFR).
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- 2019
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8. Allergic contact dermatitis to isopropyl lauroyl sarcosinate.
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Badaoui, Antoine and Soria, Angèle
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CONTACT dermatitis , *ECZEMA , *INFORMED consent (Medical law) - Abstract
The previously used make-up base could not be patch tested but similar products from the same brand were shown to contain isopropyl lauroyl sarcosinate. Keywords: allergic contact dermatitis; CAS no. 230309-38-3; case report; cosmetics; eczema; isopropyl lauroyl sarcosinate; patch test; repeated open application test; sodium lauroyl sarcosinate EN allergic contact dermatitis CAS no. 230309-38-3 case report cosmetics eczema isopropyl lauroyl sarcosinate patch test repeated open application test sodium lauroyl sarcosinate 119 120 2 06/17/21 20210701 NES 210701 We report a second case of allergic contact dermatitis caused by isopropyl lauroyl sarcosinate (CAS no. 230309-38-3), an amino acid-based ester, contained in a cosmetic.1 CASE REPORT A 35-year-old woman, with a history of chronic spontaneous urticaria and asthma, reported an erythematous and oedematous eruption of the face, with burning and itchy sensations, 24 hours following the application of Effaclar Duo+ (La Roche Posay, L'Oréal, Clichy, France) to treat acne. Allergic contact dermatitis, CAS no. 230309-38-3, case report, cosmetics, eczema, isopropyl lauroyl sarcosinate, patch test, repeated open application test, sodium lauroyl sarcosinate. [Extracted from the article]
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- 2021
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9. Characterization of the T cell response in allergic contact dermatitis caused by corticosteroids.
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Baeck, Marie, Soria, Angèle, Marot, Liliane, Theate, Ivan, Hendrickx, Emilie, Van Belle, Astrid, Goossens, An, Tennstedt, Dominique, Dachelet, Claire, Jaeger, Johnathan, Pilette, Charles, Renauld, Jean‐Christophe, Van Baren, Nicolas, Rozières, Aurore, Nicolas, Jean‐Fançois, and Dumoutier, Laure
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T cells , *CONTACT dermatitis , *CORTICOSTEROIDS , *CYTOKINES , *INTERLEUKIN-4 , *T cell receptors , *LYMPHOCYTES - Abstract
Background Delayed allergic hypersensitivity reactions have classically been described as type IV reactions, which are caused by T cells; however, the respective roles of CD4+ and CD8+ cells are yet to be defined. A central role for CD8+ cytotoxic T cells as effector cells has been suggested. Objectives To determine the type of T cell involved in corticosteroid allergy. Methods We analysed the kinetics of T cell recruitment and the cytokine production profile in positive patch tests of 27 corticosteroid-sensitized patients, as compared with control sites and control subjects. Skin biopsies, collected at 8, 24 and 48 hr following drug application, were embedded in paraffin for histological and immunohistological staining, and, in some cases, also deep-frozen for gene expression analyses. Results CD3+ T cells were rapidly recruited in concert with the positivity of the patch test sites. High levels of interleukin (IL)-4, IL-5 and, to a lesser extent, interferon- γ suggested that both Th2 and Th1 cytokines were implicated. IL-4 was also produced by γδ T cell receptor (TCR) lymphocytes. Conclusions This study showed that, in allergic contact dermatitis caused by corticosteroids, the inflammatory infiltrate is composed of CD3+ T cells with a predominant Th2 cytokine profile, among which IL-4 is also produced by γδ TCR lymphocytes. [ABSTRACT FROM AUTHOR]
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- 2013
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10. Patch, prick or intradermal tests to detect delayed hypersensitivity to corticosteroids?
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Soria, Angèle, Baeck, Marie, Goossens, An, Marot, Liliane, Duveille, Vèronique, Derouaux, Anne-Sophie, Nicolas, Jean-François, and Tennstedt, Dominique
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ALLERGIES , *SKIN inflammation , *SKIN diseases , *CORTICOSTEROIDS , *ALLERGENS , *PHYSIOLOGICAL effects of chemicals - Abstract
Contact allergy to topical corticosteroids is usually detected by patch testing. This study compares the test results obtained with patch, prick and intradermal testing, to assess the most sensitive method for diagnosing corticosteroid hypersensitivity. Nineteen corticosteroid-allergic subjects and three control subjects were included. Patch, prick and intradermal tests were performed with five commercial corticosteroid preparations, as well as with the respective active principles diluted in ethanol. The test readings were performed at different time points, i.e. at 8, 24, 48 and 96 hr, and at 7 days. Patch tests with ethanolic preparations produced more positive reactions than the commercial ones. The intradermal tests became positive earlier than the patch tests, a concordance between patch and intradermal tests being found in 11/15 (two positive intradermal test results with negative patch test results and vice versa). However, several subjects developed skin atrophy (14/22) at intradermal injection sites. Patch testing with the active principles diluted in ethanol remains the diagnostic method of choice for the detection of delayed hypersensitivity to corticosteroids. Intradermal tests with late readings, despite detecting additional contact allergy cases, should not be routinely performed, because of an important risk of atrophy, particularly with corticosteroid suspensions. [ABSTRACT FROM AUTHOR]
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- 2011
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11. Long-term maintenance of skin immune system in a NOD-Scid IL2r γnull mouse model transplanted with human skin.
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Soria, Angèle, Boccara, David, Chonco, Louis, Yahia, Nora, Dufossée, Mélody, Cardinaud, Sylvain, Moris, Arnaud, Liard, Christelle, Joulin‐Giet, Alix, Julithe, Marion, Mimoun, Maurice, Combadière, Béhazine, and Perrin, Hélène
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IMMUNE system , *INTERLEUKIN-2 receptors , *IMMUNODEFICIENCY , *T cells , *SKIN diseases , *ALLERGIES , *LABORATORY mice - Abstract
We developed a NOD-Scid IL2rγnull mouse model transplanted with human skin that brings fundamental insight on in vivo cellular mechanisms of intradermal immunization and antigen presentation by dermal dendritic and epidermal Langerhans cells for skin T-cell immunity. Indeed, T-cell immunity is a crucial checkpoint for the induction of in vivo rapid control of skin infection. With the long-term preservation of a complete human skin immune system, this model offers the unique opportunity not only to better understand mechanisms of skin immune response but also to test new compounds and devices for cutaneous routes of vaccination, as well as new therapeutics approach for skin diseases, allergies or infections. [ABSTRACT FROM AUTHOR]
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- 2014
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12. Efficacy and tolerance of dupilumab in patients with moderate‐to‐severe atopic dermatitis and obesity.
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Dupuis, Joséphine, Tauber, Marie, Mahe, Emmanuel, Jachiet, Marie, Soria, Angèle, Tetart, Florence, Puzenat, Eve, Pasteur, Justine, Raison‐Peyron, Nadia, Giordano‐Labadie, Françoise, Droitcourt, Catherine, Leleu, Camille, Nosbaum, Audrey, Aubert, Hélène, Moigne, Marie L. E., Bernier, Claire, Barbarot, Sébastien, Ezzedine, Khaled, Diaz, Emmanuelle, and Hubiche, Thomas
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MAJOR adverse cardiovascular events , *CLINICAL drug trials , *BODY mass index , *FISHER exact test , *SEBORRHEIC dermatitis - Abstract
This article discusses a study on the drug dupilumab and its effectiveness in treating atopic dermatitis (AD) in obese patients. The study found that dupilumab was effective in treating AD in obese patients, although the response rate was slightly lower compared to non-obese patients. The study also observed weight changes in both groups, with some patients experiencing weight gain and others experiencing weight loss. The authors recommend weight monitoring during treatment and suggest that optimized dosages may be considered for obese patients. The study was supported by the FRADEN/F-CRIN network and the authors disclose potential conflicts of interest. This document is a letter to the editor written by dermatologists and researchers from various hospitals and institutions in France. The letter discusses the potential factors influencing dupilumab response, the impact of body mass index on treatment outcomes, and weight gain in patients receiving dupilumab. The study was approved by an ethics committee and the data supporting the findings are available upon request. [Extracted from the article]
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- 2024
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13. Characterization of omalizumab updosing patterns and predictive factors in chronic spontaneous urticaria: A prospective multicentric observational study.
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Pierrard, Guillaume, Bernier, Claire, Du‐Thanh, Aurélie, Bara, Corina, Soria, Angèle, Castelain, Florence, Boccon‐Gibod, Isabelle, Hacard, Florence, Delaunay, Juliette, De Montjoye, Laurence, Staumont‐Salle, Delphine, and Dezoteux, Frédéric
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URTICARIA , *OMALIZUMAB , *LYMPHOCYTE count , *SCIENTIFIC observation , *IMMUNOGLOBULIN E , *INJECTIONS - Abstract
Background Methods Results Conclusion Limited information is available on the use of omalizumab (OMA) updosing since its introduction as a second‐line therapy in chronic spontaneous urticaria (CSU) in 2014. Practical guidelines from health authorities are lacking, and the specific characteristics of patients requiring higher doses remain unknown. Our objectives were to characterize the patterns of OMA updosing (defined as changes in dose and/or injection intervals), to identify the predictive factors associated with updosing, and to improve CSU management.We conducted a prospective, multicentric, real‐life observational study, including patients diagnosed with CSU and starting OMA. The data were collected at 0, 3, 6, and 9 months. The primary endpoint was the frequency of OMA updosing at 3 months. The secondary endpoints included an analysis of updosed patients' profile, and an assessment of OMA efficacy and safety.We included 153 patients. Twenty percent of patients were updosed at 3 months, and 27% in total during the 9‐month follow‐up. Practitioners mainly chose to increase the frequency of injections (66%). At baseline, the updosed patients were more likely to have more severe CSU (UCT < 4, p < 0.030), a lower lymphocyte count (<2000/mm3, p = 0.037), and low IgE levels (<70 UI/mL, p = 0.024). The side effects of OMA were not more frequent after updosing.One in five patient underwent updosing within just 3 months. OMA updosing is frequent in particular in cases of severe disease and low IgE blood levels. [ABSTRACT FROM AUTHOR]
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- 2024
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14. What is the optimal duration for a ROAT? The experience of the French Dermatology and Allergology group (DAG).
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Amsler, Emmanuelle, Assier, Haudrey, Soria, Angèle, Bara, Corina, Ferrier le Bouëdec, Marie Christine, Barbaud, Annick, Milpied, Brigitte, Giordano‐Labadie, Françoise, Pasteur, Justine, Badaoui, Antoine, Valois, Aude, Castelain, Florence, Kurihara, Flore, Castagna, Julie, Boulard, Claire, Bernier, Claire, Leleu, Camille, Marcant, Pierre, Crépy, Marie Noelle, and Tetart, Florence
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CONTACT dermatitis , *DERMATOLOGY , *SKIN tests , *LONGITUDINAL method - Abstract
Background and Objectives: The repeated open application test (ROAT) is an adjuvant investigation measure to patch testing in the diagnosis of allergic contact dermatitis. ESCD recommends a 15 days duration but its overall duration varies according to publications and patients hardly adhere to prolonged ROAT duration beyond 1 week. Materials and Methods: The Dermatology and Allergy Group of the French Society of Dermatology performed a prospective study with the aim of determining the best duration for the ROAT. Results: A total of 328 ROAT results were collected for topical products, including cosmetics (60%) and topical medications (31.1%). Fifty‐nine (18%) ROATs were positive, and 16 (5%) were doubtful. All the positive ROATs occurred within 10 days, with a median time to positivity of 3 days. Conclusion: According to our results, a minimum duration of 10 days is necessary to achieve a positive ROAT to a topical product. [ABSTRACT FROM AUTHOR]
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- 2022
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15. Skin tests in the work‐up of cutaneous adverse drug reactions: A review and update.
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Barbaud, Annick, Castagna, Julie, and Soria, Angèle
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DRUG side effects , *SKIN tests , *DRUG eruptions , *TOXIC epidermal necrolysis - Abstract
Skin tests, including patch tests (PTs), prick tests, and intradermal tests (IDTs), are useful in identifying the culprits of cutaneous adverse drug reactions (CADRs), and determining safer, alternative drugs. PTs have a low sensitivity but are valuable in investigating maculopapular exanthema (MPE), as well as severe CADR, including toxic epidermal necrolysis (TEN), Stevens‐Johnson syndrome (SJS), and in particular, acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). To ensure their specificity, at least 10 control tests should be performed. Prick tests are mainly used in the evaluation of immediate‐type hypersensitivity and can be performed with all drugs, except opiates. IDTs can be used to explore immediate and delayed‐type hypersensitivity, if an injectable form of the drug exists. Except for SJS/TEN, IDTs should be performed by injecting 0.02 mL of the drug. We here provide a practical, up‐to‐date review on the use of these skin tests in the work‐up of CADRs. Numerous negative controls for drug PTs, as well as criteria for the immediate and delayed positivity of prick tests and IDT, are included. It should be emphasized that a negative result never excludes the potential responsibility of a drug in a CADR. [ABSTRACT FROM AUTHOR]
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- 2022
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16. Doxycycline‐induced fixed drug eruption: The new epidemic?
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Brehon, Alice, Lourenco, Jérémy, Badaoui, Antoine, Amsler, Emmanuelle, Lopez Zaragoza, José Luis, Soria, Angèle, and Barbaud, Annick
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DRUG side effects , *HERPES simplex , *DRUG eruptions , *SEXUALLY transmitted diseases , *MEN who have sex with men - Abstract
This article discusses the emergence of doxycycline-induced fixed drug eruption (FDE), a common adverse reaction characterized by red patches on the skin or mucosa. FDE is typically associated with drugs like paracetamol, antibiotics, and non-steroidal anti-inflammatory drugs. However, recent cases have shown that doxycycline, commonly used for post-exposure prophylaxis (PeP) against sexually transmitted infections (STIs), can also induce FDE. The article presents 15 cases of doxycycline-induced FDE, with most cases occurring within the past 6 months. The authors recommend in situ repeated open application tests (ROAT) to confirm the diagnosis and avoid oral provocation tests (OPT), which can carry risks. They also suggest that all cyclin antibiotics, including doxycycline, be contraindicated for safety reasons. The article emphasizes the importance of recognizing doxycycline-induced FDE, particularly in cases of genital lesions that could be misdiagnosed as STIs. [Extracted from the article]
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- 2024
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17. Guidelines for cold urticaria management established by the Centre of Evidence of Dermatology and the Urticaria Group of the French Society of Dermatology.
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Bréhon, Alice, Bensefa-Colas, Lynda, D'Andrea, Cyril, Jeziorski, Eric, Lehucher-Michel, Marie-Pascale, Lequipe, Johan, Marmion, Nicolas, Mathelier-Fusade, Pascale, Mercier, Jean-Christophe, Sebatigita, Georges, Tannous, Julio, Vigan, Martine, Guillot, Bernard, Du-Thanh, Aurélie, and Soria, Angèle
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URTICARIA , *GENERAL practitioners , *DERMATOLOGY - Abstract
The article presents guidelines for the management of cold urticaria, a rare condition characterized by skin lesions and potentially life-threatening systemic reactions to cold exposure. The guidelines recommend limited paraclinical examinations, such as blood count and C-reactive protein tests, to rule out other diseases. The guidelines also propose a severity classification for cold urticaria and recommend the use of an ice cube test for diagnosis. Treatment options include antihistamines and, in severe cases, autoinjectable adrenaline kits and omalizumab. The guidelines were developed by a multidisciplinary working group and are available on a dedicated website. [Extracted from the article]
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- 2024
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18. Effect of abrocitinib and dupilumab on eosinophil levels in patients with moderate‐to‐severe atopic dermatitis.
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Staumont‐Sallé, Delphine, Barbarot, Sébastien, Bouaziz, Jean David, Chan, Chan, Clibborn, Claire, Du‐Thanh, Aurélie, Feeney, Claire, Lejeune, Alexandre, Misery, Laurent, Nosbaum, Audrey, Seneschal, Julien, Soria, Angèle, and Zhang, Fan
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- 2023
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19. Allergic contact dermatitis from essential oil in consumer products: Mode of uses and value of patch tests with an essential oil series. Results of a French study of the DAG (Dermato‐Allergology group of the French Society of Dermatology).
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Barbaud, Annick, Kurihara, Flore, Raison‐Peyron, Nadia, Milpied, Brigitte, Valois, Aude, Assier, Haudrey, Morice, Cécile, Manciet, Jean Romain, Gener, Gwendeline, Giordano‐Labadie, Françoise, Marcant, Pierre, Bernier, Claire, Amsler, Emmanuelle, Crepy, Marie Noelle, Tetart, Florence, Soria, Angèle, and le Bouëdec, Marie‐Christine Ferrier
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ESSENTIAL oils , *TEA tree oil , *CONSUMER goods , *CONTACT dermatitis , *ECZEMA - Abstract
Objective: To analyse the clinical characteristics and sensitivity of an essential oil patch test series (EOS) in patients sensitized to their own essential oils (EOs). Method: We analysed the clinical data and patch test results obtained with the European baseline series (BSE) and an EOS, as well as the mode of use of EOs, through a questionnaire included in the patient file. Results: The study included 42 patients (79% women, average age 50 years) with allergic contact dermatitis (ACD), 8 patients required hospitalization. All patients were sensitized to the EO they used, primarily lavender (Lavandula augustifolia, 8000‐28‐0), tea tree (Melaleuca alternifolia leaf oil, 68647‐73‐4), ravintsara (Cinnamomum camphora oil, 92201‐50‐8), and 2 cases were attributed to helichrysum (helichrysum italicum flower absolute, 90045‐56‐0). 71% had positive patch tests to fragrance mix I or II, 9 only to the EOS and 4 only with their personal EO. Interestingly, 40% of patients did not spontaneously mention the use of EOs, and only 33% received advice on their use at the time of purchase. Conclusion: Patch tests with the BSE, limonene and linalool HP, and oxidized tea tree oil is sufficient to detect most EO‐sensitized patients. The most important is to test the patient's own used EOs. [ABSTRACT FROM AUTHOR]
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- 2023
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20. Innate gene signature distinguishes humoral versus cytotoxic responses to influenza vaccination.
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Gonçalves, Eléna, Bonduelle, Olivia, Soria, Angèle, Loulergue, Pierre, Rousseau, Alexandra, Cachanado, Marine, Bonnabau, Henri, Thiebaut, Rodolphe, Tchitchek, Nicolas, Behillil, Sylvie, van der Werf, Sylvie, Vogt, Annika, Simon, Tabassome, Launay, Odile, and Combadière, Behazine
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INFLUENZA vaccines , *CYTOTOXIC T cells , *HUMORAL immunity , *VACCINE effectiveness , *T cells , *LOGISTIC regression analysis , *INFLUENZA prevention , *CYTOKINES , *IMMUNIZATION , *PROTEOLYTIC enzymes , *ANTIBODY formation , *GENE expression profiling , *INFLUENZA , *CELLULAR immunity , *VIRAL antibodies , *INFLUENZA A virus, H3N2 subtype , *INFLUENZA A virus, H1N1 subtype - Abstract
Background: Systems vaccinology allows cutting-edge analysis of innate biomarkers of vaccine efficacy. We have been exploring novel strategies to shape the adaptive immune response, by targeting innate immune cells through novel immunization routes.Methods: This randomized phase I/II clinical study (n=60 healthy subjects aged 18-45 years old) used transcriptomic analysis to discover early biomarkers of immune response quality after transcutaneous (t.c.), intradermal (i.d.), and intramuscular (i.m.) administration of a trivalent influenza vaccine (TIV season 2012-2013) (1:1:1 ratio). Safety and immunogenicity (hemagglutinin inhibition (HI), microneutralization (MN) antibodies and CD4, CD8 effector T cells) were measured at baseline Day (D)0 and at D21. Blood transcriptome was analyzed at D0 and D1.Results: TIV-specific CD8+GranzymeB+(GRZ) T cells appeared in more individuals immunized by the t.c. and i.d. routes, while immunization by the i.d. and i.m. routes prompted high levels of HI antibody titers and MN against A/H1N1 and A/H3N2 influenza viral strains. The early innate gene signature anticipated immunological outcome by discriminating two clusters of individuals with either distinct humoral or CD8 cytotoxic responses. Several pathways explained this dichotomy confirmed by nine genes and serum level of CXCL10 were correlated with either TIV-specific cytotoxic CD8+GRZ+ T-cell or antibody responses. A logistic regression analysis demonstrated that these nine genes and serum levels of CXCL10 (D1/D0) best foreseen TIV-specific CD8+GRZ+ T-cell and antibody responses at D21.Conclusion: This study provides new insight into the impact of immunization routes and innate signature in the quality of adaptive immune responses. [ABSTRACT FROM AUTHOR]- Published
- 2019
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21. The immunological effects of intradermal particle-based vaccine delivery using a novel microinjection needle studied in a human skin explant model.
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Beaujean, Manon, Uijen, Rienke F., Langereis, Jeroen D., Boccara, David, Dam, Denise, Soria, Angèle, Veldhuis, Gert, Adam, Lucille, Bonduelle, Olivia, van der Wel, Nicole N., Luirink, Joen, Pedruzzi, Eric, Wissink, Jeroen, de Jonge, Marien I., and Combadière, Behazine
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MICROINJECTIONS , *EXTRACELLULAR vesicles , *LANGERHANS cells , *DENDRITES , *HUMAN experimentation , *VACCINES - Abstract
For intradermal (ID) immunisation, novel needle-based delivery systems have been proposed as a better alternative to the Mantoux method. However, the penetration depth of needles in the human skin and its effect on immune cells residing in the different layers of the skin has not been analyzed. A novel and user-friendly silicon microinjection needle (Bella-muTM) has been developed, which allows for a perpendicular injection due to its short needle length (1.4–1.8 mm) and ultrashort bevel. We aimed to characterize the performance of this microinjection needle in the context of the delivery of a particle-based outer membrane vesicle (OMV) vaccine using an ex vivo human skin explant model. We compared the needles of 1.4 and 1.8 mm with the conventional Mantoux method to investigate the depth of vaccine injection and the capacity of the skin antigen-presenting cell (APC) to phagocytose the OMVs. The 1.4 mm needle deposited the antigen closer to the epidermis than the 1.8 mm needle or the Mantoux method. Consequently, activation of epidermal Langerhans cells was significantly higher as determined by dendrite shortening. We found that five different subsets of dermal APCs are able to phagocytose the OMV vaccine, irrespective of the device or injection method. ID delivery using the 1.4 mm needle of a OMV-based vaccine allowed epidermal and dermal APC targeting, with superior activation of Langerhans cells. This study indicates that the use of a microinjection needle improves the delivery of vaccines in the human skin. [ABSTRACT FROM AUTHOR]
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- 2023
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22. Chemical characterization of inks in skin reactions to tattoo.
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Colboc, Hester, Bazin, Dominique, Reguer, Solenn, Lucas, Ivan T., Moguelet, Philippe, Amode, Reyhan, Jouanneau, Chantal, Soria, Angèle, Chasset, François, Amsler, Emmanuelle, Pecquet, Catherine, Aractingi, Sèlim, Bellot-Gurlet, Ludovic, Deschamps, Lydia, Descamps, Vincent, and Kluger, Nicolas
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X-ray absorption near edge structure , *TATTOOING , *X-ray fluorescence , *RAMAN spectroscopy , *X-ray spectroscopy - Abstract
Skin reactions are well described complications of tattooing, usually provoked by red inks. Chemical characterizations of these inks are usually based on limited subjects and techniques. This study aimed to determine the organic and inorganic composition of inks using X-ray fluorescence spectroscopy (XRF), X-ray absorption spectroscopy (XANES) and Raman spectroscopy, in a cohort of patients with cutaneous hypersensitivity reactions to tattoo. A retrospective multicenter study was performed, including 15 patients diagnosed with skin reactions to tattoos. Almost half of these patients developed skin reactions on black inks. XRF identified known allergenic metals - titanium, chromium, manganese, nickel and copper - in almost all cases. XANES spectroscopy distinguished zinc and iron present in ink from these elements in endogenous biomolecules. Raman spectroscopy showed the presence of both reported (azo pigments, quinacridone) and unreported (carbon black, phtalocyanine) putative organic sensitizer compounds, and also defined the phase in which Ti was engaged. To the best of the authors' knowledge, this paper reports the largest cohort of skin hypersensitivity reactions analyzed by multiple complementary techniques. With almost half the patients presenting skin reaction on black tattoo, the study suggests that black modern inks should also be considered to provoke skin reactions, probably because of the common association of carbon black with potential allergenic metals within these inks. Analysis of more skin reactions to tattoos is needed to identify the relevant chemical compounds and help render tattoo ink composition safer. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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23. Allergic contact dermatitis from oleoyl tyrosine in a sunscreen.
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Badaoui, Antoine, Vergez, Mylène, and Soria, Angèle
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CONTACT dermatitis , *ECZEMA , *TYROSINE , *SUNSCREENS (Cosmetics) , *AMINO acid amides - Published
- 2021
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24. Allergies and COVID‐19 vaccines: An ENDA/EAACI Position paper.
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Barbaud, Annick, Garvey, Lene Heise, Arcolaci, Alessandra, Brockow, Knut, Mori, Francesca, Mayorga, Cristobalina, Bonadonna, Patrizia, Atanaskovic‐Markovic, Marina, Moral, Luis, Zanoni, Giovanna, Pagani, Mauro, Soria, Angèle, Jošt, Maja, Caubet, Jean‐Christoph, Carmo, Abreu, Mona, Al‐Ahmad, Alvarez‐Perea, Alberto, Bavbek, Sevim, Benedetta, Biagioni, and Bilo, M.Beatrice
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COVID-19 vaccines , *POLYSORBATE 80 , *SCIENTIFIC literature , *ALLERGIES , *DRUG allergy - Abstract
Background: Anaphylaxis, which is rare, has been reported after COVID‐19 vaccination, but its management is not standardized. Method: Members of the European Network for Drug Allergy and the European Academy of Allergy and Clinical Immunology interested in drug allergy participated in an online questionnaire on pre‐vaccination screening and management of allergic reactions to COVID‐19 vaccines, and literature was analysed. Results: No death due to anaphylaxis to COVID‐19 vaccines has been confirmed in scientific literature. Potential allergens, polyethylene glycol (PEG), polysorbate and tromethamine are excipients. The authors propose allergy evaluation of persons with the following histories: 1—anaphylaxis to injectable drug or vaccine containing PEG or derivatives; 2—anaphylaxis to oral/topical PEG containing products; 3—recurrent anaphylaxis of unknown cause; 4—suspected or confirmed allergy to any mRNA vaccine; and 5—confirmed allergy to PEG or derivatives. We recommend a prick‐to‐prick skin test with the left‐over solution in the suspected vaccine vial to avoid waste. Prick test panel should include PEG 4000 or 3500, PEG 2000 and polysorbate 80. The value of in vitro test is arguable. Conclusions: These recommendations will lead to a better knowledge of the management and mechanisms involved in anaphylaxis to COVID‐19 vaccines and enable more people with history of allergy to be vaccinated. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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25. Sweet‐like syndrome and multiple COVID arm syndrome following COVID‐19 vaccines: 'specific' patterns in a series of 192 patients.
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Darrigade, Anne‐Sophie, Oulès, Bénédicte, Sohier, Pierre, Jullie, Marie‐Laure, Moguelet, Philippe, Barbaud, Annick, Soria, Angèle, Vignier, Nicolas, Lebrun‐Vignes, Bénédicte, Sanchez‐Pena, Paola, Chosidow, Olivier, Beylot‐Barry, Marie, Milpied, Brigitte, and Dupin, Nicolas
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COVID-19 vaccines , *COVID-19 , *SYNDROMES , *SWEET'S syndrome , *DRUG eruptions - Abstract
Of the seven patients in this subset, six had further injections and only one relapsed, although less severely, and two patients presented with different cutaneous reactions following the next injection. Only two patients had a classical Sweet syndrome histology showing a diffuse dermal neutrophilic infiltrate, while two had a dermal infiltrate of histiocyte-like immature myeloid cells compatible with histiocytoid Sweet syndrome (Figure 1c, d). Sweet-like syndrome and multiple COVID arm syndrome following COVID-19 vaccines: "specific" patterns in a series of 192 patients. [Extracted from the article]
- Published
- 2022
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26. Dysregulation of microRNA expression in the skin during cutaneous adverse drug reactions.
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Pedruzzi, Eric, Chasset, François, Duroux‐Richard, Isabelle, Bocarra, David, Apparailly, Florence, Nourikyan, Julien, Lumy, Mathilde, Bernard, Simon, Bonduelle, Olivia, Buffat, Laurent, Combadière, Behazine, and Soria, Angèle
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TOXIC epidermal necrolysis , *DRUG side effects , *DRESS syndrome - Abstract
Keywords: drug reaction with eosinophilia and systemic symptoms; maculopapular exanthema; microRNAs EN drug reaction with eosinophilia and systemic symptoms maculopapular exanthema microRNAs 3279 3283 5 12/03/20 20201201 NES 201201 Abbreviations cADR atopic dermatitis DRESS drug reaction with eosinophilia and systemic symptoms HC healthy controls MiRNA microRNA MPE maculopapular exanthema PCA principal component analyses To the Editor, The diagnosis of drug reaction with eosinophilia and systemic symptoms (DRESS), is challenging due to its heterogeneous clinical presentation and complex natural course.1 It is therefore sometimes difficult, at an early stage, to differentiate between maculopapular exanthema (MPE) and DRESS due to overlapping clinical presentations.2,3 To better characterize cutaneous adverse drug reactions (cADRs), several approaches have been proposed. Briefly, skin and blood samples were obtained from MPE (n = 6) patients, DRESS (n = 6) patients and HCs (n = 6). Overall, these 34 miRNA-based signatures correctly separated MPE and DRESS patients, except for 2 MPE patients (E2 and E4; Table 1) with herpes viral replication, who had skin miRNA expression profiles more similar to DRESS. Only blood miR-185-3p was significantly higher in MPE compared to HC samples (FC x1.5, adjusted I P i -value.03) (Appendix S3), and none of the blood miRNAs were differentially expressed between DRESS and HC patients, probably due to small sample size. [Extracted from the article]
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- 2020
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27. Vocational Guidance for Young Patients with Atopic Dermatitis: A Survey of Physicians' Opinions and Practices.
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CRÉPY, Marie-Noëlle, BENSEFA-COLAS, Lynda, AUBIN, François, SIMON, Michel, and SORIA, Angèle
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VOCATIONAL guidance , *ATOPIC dermatitis , *PHYSICIANS , *ECZEMA , *HAZARDOUS occupations , *ATOPY - Abstract
The article focuses on a survey of opinions and practices of physicians regarding vocational guidance for young patients with atopic dermatitis (AD). It informs that the studies have shown that the barrier function of the skin in patients with AD is reduced, even in uninvolved skin areas, compared with healthy controls.
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- 2022
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28. Occurrence of immediate and delayed hypersensitivity to hexamidine.
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Le Seac'h, Agathe, Castagna, Julie, Chantran, Yannick, Kurihara, Flore, Amsler, Emmanuelle, Soria, Angèle, and Barbaud, Annick
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DELAYED hypersensitivity , *ALLERGIES , *ECZEMA , *URTICARIA , *ANAPHYLAXIS , *ALLERGIC rhinitis , *ATOPIC dermatitis - Abstract
(C) Positive prick test with undiluted Desomedine on delayed reading at day 2 (same prick test as in B) gl Prick tests were performed with undiluted Desomedine (hexamidine 0.1%), and these confirmed both immediate and delayed type hypersensitivity on immediate (Figure 1B) and delayed readings on day (D)2 (Figure 1C). Although allergic contact dermatitis in response to antiseptics is common, we should be aware that occasionally this may co-exist with immediate-type hypersensitivity, and also with molecules frequently sold over the counter. Keywords: case report; delayed hypersensitivity; hexamidine; immediate hypersensitivity EN case report delayed hypersensitivity hexamidine immediate hypersensitivity 580 582 3 10/22/21 20211101 NES 211101 CASE REPORT A 66-year-old man with a history of arterial hypertension (treated by dietary approaches only), allergic rhinitis, asthma, and atopic dermatitis, developed a grade II anaphylactic reaction 5 minutes after the first intranasal application of hexamidine (Desomedine, Chauvin Bausch & Lomb laboratory, Montpellier, France) for a cold. [Extracted from the article]
- Published
- 2021
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29. Tert‐butylhydroquinone is a marker for sensitivity to Nigella sativa oil allergy: Five new cases.
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Seiller, Hélène, Kurihara, Flore, Chasset, François, Soria, Angèle, and Barbaud, Annick
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BLACK cumin , *ECZEMA , *ALLERGIES , *PETROLEUM , *TUMOR suppressor genes , *VEGETABLE oils - Abstract
Thereby, the similar patch test profile results in our five patients support the hypothesis that TBHQ is a good marker for NSO allergy through a TQ sensitization. Keywords: allergic contact dermatitis; Cas number 1948-33-0; patch test; Nigella sativa oil; tert-butylhydroquinone; thymoquinone EN allergic contact dermatitis Cas number 1948-33-0 patch test Nigella sativa oil tert-butylhydroquinone thymoquinone 447 449 3 05/06/21 20210601 NES 210601 Use of complementary and alternative medicine has increased in industrialized countries.1,2 I Nigella sativa i oil (NSO), used as an herbal medicine for thousands of years, has drawn interest for its immunoregulatory, antimicrobial, cardiovascular, and antitumoral properties.3 Although patients expect alternative medicine to be safe,4 allergic contact dermatitis (ACD) and bullous dermatitis with NSO have been reported.5,6 The hypothesis that thymoquinone (TQ), its major component, is the causative substance of allergic reaction to NSO was proposed,7 but thymoquinone is not yet available in France for patch tests. These five cases and the previously published one support the hypothesis that due to chemical similarities with TQ, which is supposed to be the responsible for NSO sensitization, TBHQ would be a good marker for NSO allergy. [Extracted from the article]
- Published
- 2021
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30. Low‐dose provocation and skin tests in patients with hypersensitivity to gadolinium‐based contrast agents.
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Seta, Vannina, Gaouar, Hafida, Badaoui, Antoine, Francès, Camille, Barbaud, Annick, and Soria, Angèle
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SKIN tests , *URTICARIA , *PROVOCATION (Behavior) , *ALLERGIES - Abstract
The article focuses on the gadolinium-based contrast agents (GBCA) around the rate of hypersensitivity reaction (HS). It discusses the aim of evaluating the skin tests and intravenous provocation test (IPT), how skin prick tests (PTs) were performed and then intradermal tests were performed if negative.
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- 2019
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31. Drug‐induced linear immunoglobulin A bullous dermatosis: A French retrospective pharmacovigilance study of 69 cases.
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Garel, Bethsabée, Ingen‐Housz‐Oro, Saskia, Afriat, Daniele, Prost‐Squarcioni, Catherine, Tétart, Florence, Bensaid, Benoit, Bara Passot, Corina, Beylot‐Barry, Marie, Descamps, Vincent, Duvert‐Lehembre, Sophie, Grootenboer‐Mignot, Sabine, Jeudy, Géraldine, Soria, Angèle, Valnet‐Rabier, Marie Blanche, Barbaud, Annick, Caux, Frédéric, and Lebrun‐Vignes, Bénédicte
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IMMUNOGLOBULIN A , *BLISTERS , *RETROSPECTIVE studies , *DRUG side effects , *VANCOMYCIN , *TOXIC epidermal necrolysis , *FOLLOW-up studies (Medicine) - Abstract
Aims: Linear immunoglobin A (IgA) bullous dermatosis is a rare autoimmune dermatosis considered spontaneous or drug‐induced (DILAD). We assessed all DILAD cases, determined the imputability score of drugs and highlighted suspected drugs. Methods: Data for patients with DILAD were collected retrospectively from the French Pharmacovigilance network (from 1985 to 2017) and from physicians involved in the Bullous Diseases French Study Group and the French Investigators for Skin Adverse Reactions to Drugs. Drug causality was systematically determined by the French imputability method. Results: Of the 69 patients, 42% had mucous membrane involvement, 20% lesions mimicking toxic epidermal necrolysis (TEN), 21% eosinophil infiltrates and 10% keratinocytes necrosis. Direct immunofluorescence, in 80%, showed isolated linear IgA deposits. Vancomycin (VCM) was suspected in 39 cases (57%), 11 had TEN‐like lesions, as compared with three without VCM suspected. Among the 33 patients with a single suspected drug, 85% had an intrinsic imputability score of I4. Among them, enoxaparin, minocycline and vibramycin were previously unpublished. For all patients, the suspect drug was withdrawn; 15 did not receive any treatment. First‐line therapy for 31 patients was topical steroids. Among the 60 patients with available follow‐up, 52 achieved remission, 10 without treatment. Four patients experienced relapse, four died and five had positive accidental rechallenges. Conclusions: There is no major clinical difference between DILAD and idiopathic linear IgA bullous dermatosis, but the former features a higher prevalence of patients mimicking TEN. VCM, suspected in more than half of the cases, might be responsible for more severe clinical presentations. We report three new putative drugs. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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32. Is a specific eyelid patch test series useful? Results of a French prospective study.
- Author
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for the Dermato‐Allergology Group of the French Society of Dermatology (DAG), Assier, Haudrey, Gener, Gwendeline, Waton, Julie, Truchetet, François, Bourrain, Jean‐Luc, Raison‐Peyron, Nadia, Bernier, Claire, Tetart, Florence, Avenel‐Audran, Martine, Barbaud, Annick, Amsler, Emmanuelle, Soria, Angèle, Ferrier‐le Bouëdec, Marie‐Christine, Giordano‐Labadie, Françoise, Milpied, Brigitte, Collet, Evelyne, and Girardin, Pascal
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CONTACT dermatitis , *EYELID diseases , *PATIENTS , *DIAGNOSIS , *LIMONENE - Abstract
Background: Eyelids are frequent sites of contact dermatitis. No prospective study focused on eyelid allergic contact dermatitis (EACD) has yet been published, and this topic has never been studied in French patients. Objectives: To prospectively evaluate the usefulness of an eyelid series in French patients patch tested because of EACD, and to describe these patients. Methods: We prospectively analysed standardized data for all patients referred to our departments between September 2014 and August 2016 for patch testing for suspected EACD as the main reason. All patients were patch tested with an eyelid series, the European baseline series (EBS), the French additional series, and their personal products. Patch testing with additional series and repeated open application tests (ROATs) or open tests were performed if necessary. A standardized assessment of the relevance was used, and the analysis of the results was focused on patients having positive test results with a current certain relevance. Results: Two‐hundred and sixty‐four patients (238 women and 26 men) were included. Three‐hundred and twenty‐two tests gave positive results in 167 patients, 84 of whom had currently relevant reactions: 56 had currently relevant positive test reactions to the EBS, 16 had currently relevant positive test reactions to their personal products, 8 had currently relevant positive test reactions to the French additional series, and 4 had currently relevant positive test reactions to the eyelid series. Sixty‐seven per cent of all relevant cases were related to cosmetic products. The most frequent allergens with current relevance were methylisothiazolinone (10.2%), fragrance mix I (3%), nickel (2.7%), hydroxyperoxides of linalool (2.7%) and limonene (2.3%), and Myroxylon pereirae (2.3%). Current atopic dermatitis was found in 9.5% of patients. The duration of dermatitis was shorter (23.2 vs 34.2 months; P = .035) in patients with currently relevant test reactions. The percentage of currently relevant tests remained the same when atopic patients or dermatitis localized only on the eyelids were taken into account. Conclusion: In French patients, testing for EACD with the extended baseline series and personal products, also including ROATs and use tests, appears to be adequate, considering the currently relevant positive test reactions. The regular addition of an eyelid series does not seem to be necessary. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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33. Analysis of the skin of mice humanized for the immune system.
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Centlivre, Mireille, Petit, Maxime, Hutton, Andrew J., Dufossée, Mélody, Boccara, David, Mimoun, Maurice, Soria, Angèle, and Combadière, Béhazine
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IMMUNE system , *LABORATORY mice , *T cells , *ANTIGENS , *IMMUNOTHERAPY - Abstract
Development of new immunotherapeutic strategies relies on the ability to activate the right cells at the right place and at the right moment and on the capacity of these cells to home to the right organ(s). Skin delivery has shown high potency for immunotherapeutic administration. However, an adequate in vivo model of human skin immunity is still a critical bottleneck. We demonstrated here that the skin of human immune system mice is colonized by human hematopoietic cells, mainly human T cells and that complementation with human antigen-presenting cells at the vaccination site allowed the induction of an immune response. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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34. Eyelid allergic contact dermatitis after intravitreal injections of anti‐vascular endothelial growth factor: What is the culprit? A report of 3 cases.
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De Risi‐pugliese, Tullia, Amsler, Emmanuelle, Collet, Evelyne, Francès, Camille, Barbaud, Annick, Pecquet, Catherine, and Soria, Angèle
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- *
RANIBIZUMAB , *CANCER chemotherapy , *BIOPHARMACEUTICS , *CONTACT dermatitis diagnosis , *THERAPEUTICS ,EYELID abnormalities - Abstract
The article presents a case study of a woman with acute eczema of upper and lower eyelids which caused Allergic contact dermatitis (ACD) was given intravitreal injections containing aflibercept and ranibizumab. It notes that IQ Ultra Chambers was applied with Mefix and repeated open application tests. The article discusses ACD is caused by an anti-vascular endothelial growth factor (VEGF) intravitreal injection.
- Published
- 2018
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35. A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis: study protocol for a multicentre, randomized, crossover, pragmatic trial - the PRADA trial.
- Author
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Droitcourt, Catherine, Barbarot, Sébastien, Maruani, Annabel, Darrieux, Laure, Misery, Laurent, Brenaut, Emilie, Adamski, Henri, Chabbert, Cécile, Vermersch, Annie, Weiborn, Marie, Seneschal, Julien, Taïeb, Alain, Plantin, Patrice, Maillard, Hervé, Phan, Alice, Skowron, François, Viguier, Manuelle, Staumont-Salle, Delphine, Nosbaum, Audrey, and Soria, Angèle
- Subjects
- *
PHOTOTHERAPY , *VITAMIN D , *ATOPIC dermatitis , *ANTI-inflammatory agents , *IMMUNOSUPPRESSIVE agents - Abstract
Background: Atopic dermatitis is a highly prevalent, chronic, relapsing disease in both adults and children. On the severity spectrum, lower-end patients benefit from small amounts of topical anti-inflammatory treatments (TAT), whereas higher-end patients need systemic immunosuppressants; in-between patients are treated with TAT and phototherapy. The major therapeutic challenge in this population is the long-term control of disease activity, and the current TAT-based pro-active strategy does not meet all their needs. Immunosuppressants are used as long-term control add-on treatments, but they are restricted to the most severely affected patients because of safety concerns. In addition, neither immunosuppressants nor other strategies have been properly evaluated in the long term despite long-term control having been acknowledged as one of the most important core outcome domains to be targeted in atopic dermatitis trials. Safe add-on therapies, rigorously evaluated for long-term control of the disease, are therefore needed. Phototherapy and vitamin D supplementation are both good candidates.Methods: This is a multicenter, national, randomized, superiority, crossover trial testing add-on phototherapy (one winter under spaced sessions of phototherapy and one winter under observation) among subjects receiving standard care (i.e., TAT). On the same population, we will test the long-term control provided by oral supplementation of vitamin D versus placebo in a randomized, superiority, double-blind, parallel-group trial. The primary outcomes are (1) repeat measures of the PO-SCORAD severity score over 1 year and (2) cumulate consumption of TAT (number of tubes) during the winter. They will be tested following a hierarchical testing procedure. The secondary outcomes will be measures repeated over 2 years of investigator-based severity scores, patient-reported severity and quality of life scores, serum vitamin D levels, weeks during which the disease is well-controlled, inter-visit cumulate consumption of TAT, and synthetic patient-reported satisfaction at the end of each winter.Discussion: This study includes two separate 2-year pragmatic trials designed to evaluate the efficacy of vitamin D supplementation and pro-active phototherapy for primary care atopic dermatitis patients receiving TAT on long-term control of disease activity. The experimental design enables the study of both interventions and exploration of the interaction between vitamin D and phototherapy. A pragmatic trial is particularly suited to the assessment of long-term control. This study explores the possibility of new and safe therapeutic strategies for the control of long-term atopic dermatitis, and is an example of efficacy research that is unlikely to be sponsored by industrialists. A potentially effective low-cost therapeutic strategy for long-term control is essential for patients and public health.Trial Registration: ClinicalTrials.gov Identifier: NCT02537509 , first received: 1 September 2015. [ABSTRACT FROM AUTHOR]- Published
- 2019
- Full Text
- View/download PDF
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